510(k) BK050046
- Device
- Automated Bloodborne Pathogen Test Equipment
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- 510(k) number
- BK050046
- Product code
- MZA
- Decision
- Substantially Equivalent (SE)
- Decision date
- 2006-01-13
- Date received
- 2005-08-15
- Regulation
- 510(k) Premarket Notification
- Classification name
- Test, Equipment, Automated Bloodborne Pathogen
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Clearance type
- 510(k) Special
- Third party reviewed
- No
Legacy Summary#
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FDA Review#
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